Development, Clinical Validation and Manufacturing Scale up of FIbroFix Meniscus: A mechanically advanced, tissue regenerative, meniscal cartilage repair implant

FIbroFix 半月板的开发、临床验证和制造规模扩大：一种机械先进的组织再生半月板软骨修复植入物

• 批准号: 102162
• 金额: $ 190.26万
• 依托单位: ORTHOX LIMITED
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2015
• 资助国家: 英国
• 起止时间: 2015 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=102162
• 关键词: Development; Clinical; Validation; Manufacturing; Scale

This project will further develop an implant to restore mobility and prevent deterioration of the knee joint in patients suffering from injuries to the meniscal cartilage in their knees. The implant is made from a novel material called FibroFix which is formed from a protein extracted from silk fibres called fibroin. The properties of fibroin give FibroFix devices unique advantages, allowing them to be very strong, smooth and resilient like cartilage itself, while also capable of regenerating new cartilage tissue. Further development of the FibroFix implant on this project will allow it to be used to treat the meniscal cartilage on both sides of the knee joint and also to treat the more demanding, larger, injuries to the meniscal cartilage where the painful condition osteoarthritis would otherwise be very likely to develop. The project will finalise development of this implant and complete testing in large scale trials, demonstrating that it is both safe and effective. Once this has been achieved, the project will investigate the implant’s performance in a clinical trial and scale up manufacture to enable the implant to be ready for the large patient poulation once market approval has been secured.

该项目将进一步开发一种植入物，以恢复活动能力，并防止膝关节软骨损伤患者的膝关节退化。这种植入物是由一种名为FibroFix的新型材料制成的，这种材料是由一种从丝纤维中提取的蛋白质制成的，这种蛋白质被称为丝心蛋白。丝素蛋白的特性赋予FibroFix设备独特的优势，使它们像软骨本身一样非常坚固，光滑和有弹性，同时还能够再生新的软骨组织。FibroFix植入物在该项目中的进一步开发将使其能够用于治疗膝关节两侧的踝关节软骨，并治疗更苛刻，更大的踝关节软骨损伤，否则疼痛的骨关节炎很可能会发展。该项目将完成这种植入物的开发，并在大规模试验中完成测试，证明它既安全又有效。一旦实现这一目标，该项目将在临床试验中研究植入物的性能，并扩大制造规模，以便一旦获得市场批准，植入物就可以用于大型患者。